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18 Aug 2008, 9:24 pm
As background, the FDA last updated us on the link between pancreatitis and Byetta five months ago, which we covered in a post titled "More Information About Reports Of Byetta Use Being Linked To Acute Pancreatitis": The quarterly issue of the FDA's online Drug Safety Newsletter [DSN] which was published on March 18, 2008 includes an article about a postmarket safety review of Byetta (Exenatide) that associates this diabetes drug with acute pancreatitis. … [read post]
1 Aug 2008, 8:03 pm
Anyway, NullRiver, Inc. [read post]
31 Jul 2008, 5:30 pm
Regardless of what the FDA ordered in 2007, if [defendant] had evidence of a reasonable association between [the drug] and adult suicidality in 2002, it had the duty then under the FDA's regulations to strengthen the warnings on [the drug's] label. [read post]
30 Jul 2008, 10:22 pm
The plant's products are distributed across the country under brands including Aaron's Best and Aaron's Choice. [read post]
22 Jul 2008, 3:10 pm
It resulted in 13 major and 10 minor malformations in combination with other epilepsy therapies including Sanofi-Aventis' Frisium, Sabril, Epilim or Depakine, Pfizer Inc.'s Zarontin, UCB SA's Keppra as well as generic drugs carbamazepine, phenobarbitral or phenytoin. [read post]
21 Jul 2008, 11:30 am
I've previously written about some of these cases, including Sports Legends, Inc. v. [read post]
20 Jul 2008, 2:00 pm
As easily the Medical Doctor as she was your aunt Sadie. [read post]
16 Jul 2008, 9:41 pm
But do you want your doctor experimenting on your appendix, or someone else's? [read post]
10 Jul 2008, 6:46 pm
The Court ruled that the regulation was not “saved” from ERISA preemption under the test set forth in Kentucky Association of Health Plans, Inc. v. [read post]
10 Jul 2008, 5:31 pm
We're not going to repeat ourselves, but once a doctor must be, and in fact is, involved in a prescription decision, that's when it makes sense to require the manufacturer to direct its warnings to that learned intermediary. [read post]
5 Jul 2008, 11:05 am
Here is IP Think Tank’s weekly selection of top intellectual property news breaking in the blogosphere and internet. [read post]
27 Jun 2008, 10:12 am
Ask Rhonda Joy McLean, Associate General Counsel at Time Inc., how her personal and professional backgrounds have prepared her for her in-house position at Time Inc., and she's likely to say, "I feel like everything I've ever done in my life has prepared me for this job, including the music. [read post]
23 Jun 2008, 8:13 am
Supreme Court rulings, including this month's Quanta Computer Inc. v. [read post]
13 Jun 2008, 12:12 pm
What's goin' on over in Joisey? [read post]
9 Jun 2008, 11:30 am
Loveless's introduction of referring doctors to Dr. [read post]
9 Jun 2008, 12:39 am
A ship's medical care is equivalent to the care available at a walk-in clinic. [read post]
4 Jun 2008, 3:44 pm
Inc. and Pfizer Inc., but there is also an unintended downside. [read post]
30 May 2008, 1:39 pm
Norman Edleman, chief medical officer for the American Lung Association in New York, last week said wary doctors are now using the pill only when other treatments fail. [read post]
27 May 2008, 10:06 am
U.S. 6th Circuit Court of Appeals, May 20, 2008 Sensations, Inc. v. [read post]
24 May 2008, 3:13 am
All of those actions violate the American Medical Association's policy against physician participation in executions. [read post]
